Bio-Manufacturing Support Tech

Status: Full Time – Non-exempt

Reports To: Bio-Manufacturing Support Supervisor

This position will perform support activities related to donor tissue processing while maintaining quality and regulatory compliance within their department. This person does not supervise others and will support the activities of the Bio Manufacturing Support Supervisor. This position interacts with employees in the Tissue Processing Department and may interact with other department supervisors, team leads, and personnel as necessary.

This position reports to the Bio-Manufacturing Support Supervisor. This position may provide additional support to other team leads, supervisors, or departments as requested.

• Specific Job Duties/Responsibilities
  • Develop and maintain an understanding of the requirements of the Food and Drug Administration (FDA);
    American Association of Tissue Banks (AATB);
    International Organization of Standardization (ISO) 13485;
    Medical Device Single Audit Program (MDSAP); and other regulatory jurisdictions, as applicable, to help the company lead the Medical Device and Biologics industries in quality practice
  • Adhere to Xtant Standard Operating Procedures (SOPs) and safety protocols, FDA Regulations for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) and Devices; operate in compliance with FDA, AATB, ISO, and Occupational Safety and Health Administration (OSHA) Standards
  • Develop and maintain an understanding of the Xtant products and general biological and chemical systems utilized within the Department. Know how the activities performed in the Department are controlled by and interact with the Quality System and how they affect the production of medical devices and tissues as applicable
  • Maintain a clean and safe working environment at all times and follow requirements to properly dispose of hazardous and non-hazardous waste according to OSHA regulations and Xtant SOPs
  • Responsible for decontamination, cleaning, and environmental monitoring of the cleanroom areas and non-sterile equipment used to process donor tissue
  • Responsible for maintaining inventory of processing supplies/reagents and other materials within the cleanroom environment and other areas throughout the processing facility
  • Ensure supplies are acceptable for processing use and stock is rotated using the First-In First-Out (FIFO) method. Aseptically transfer supplies into the cleanroom environment to maintain adequate inventory and whenever needed
  • Obtain environmental samples for surface, air, and water monitoring in conjunction with laboratory testing protocols
  • Assist with error investigations, and resolution, within the quality system
  • Assist in the preparation and transportation of soiled processing instruments, equipment, cleanroom garments, and biohazardous waste throughout the processing facility
  • Operate, monitor, and maintain lyophilizers (freeze‑dryers) in accordance with the manufacturer’s recommendations and equipment‑specific SOPs
  • Operate, monitor, and maintain autoclaves in accordance with the manufacturer’s recommendations and equipment‑specific SOPs
  • Transport unprocessed and processed donor tissue across campus
  • Know the appropriate storage conditions, locations, and tissue handling methods for unprocessed and processed donor tissue
  • Provide facility cleaning support to areas outside of the cleanroom environment
  • Responsible for decontamination, disinfection, cleaning, and sterilisation (where appropriate) of all non‑disposable processing instruments and equipment
  • Manually wash processing instruments and equipment according to Xtant SOPs
  • Ensure all reusable tissue processing equipment and instruments are suitable for use, including inspection and assembly if applicable
  • Prepare relevant donor processing documentation, labels, and other consumable supplies for sterilisation
  • Aseptically introduce equipment and supplies into the cleanroom environment
  • Safely operate, monitor, and maintain cleaning and sterilisation equipment in accordance with manufacturer recommendations and equipment‑specific SOPs when applicable
  • Safely prepare and handle cleaning…